Time-patterns of annualized relapse rates in randomized placebo-controlled clinical trials in relapsing multiple sclerosis: A systematic review and meta-analysis

2012 ◽  
Vol 18 (9) ◽  
pp. 1290-1296 ◽  
Author(s):  
Richard Nicholas ◽  
Sebastian Straube ◽  
Heinz Schmidli ◽  
Sebastian Pfeiffer ◽  
Tim Friede
Keyword(s):  
Multiple Sclerosis ◽  
Systematic Review ◽  
Meta Analysis ◽  
First Year ◽  
Controlled Trials ◽  
Regression To The Mean ◽  
Placebo Controls ◽  
Time Patterns ◽  
Meta Analyses ◽  
Relapsing Multiple Sclerosis

Background: Although it is known that the annualized relapse rate (ARR) in patients with multiple sclerosis (MS) changes as disease progresses, in the design and analysis of trials in relapsing multiple sclerosis (RMS) constant ARRs are assumed. Objectives: This paper aims to assess time-patterns of trial ARR by conducting a systematic review of randomized, placebo-controlled trials in RMS. Methods: A systematic literature search was conducted by searching PubMed for randomized, placebo-controlled trials in RMS. In meta-analyses the following comparisons of trial ARR were carried out for the placebo controls and active treatment arms: months 1–6 vs. months 7–12, and months 1–12 vs. months 13–24. Results: A total of 52 trials was identified. Out of these, information on the time-dependence of trial ARR could be extracted from 13 trials. The ARR was by 25% ( p = 0.0005) and 40% ( p < 0.0001) higher in months 1–12 compared with months 13–24 for placebo and active treatments, respectively. Consequently, the treatment effects were by 13% ( p = 0.23) larger in the second year compared with the first year. Within the first year of follow-up the ARR was by 4% ( p = 0.75) and 23% ( p = 0.06) higher in months 1–6 compared with months 7–12 for placebo controls and active arms, respectively. Conclusions: Trial ARR decreases during a trial in RMS, which is in line with epidemiological findings and has implications for design and analysis of future trials. The observed decrease in trial ARR might be at least partially explained by regression to the mean. Individual patient data analyses are warranted.

scholarly journals Pre-Procedural Lumbar Neuraxial Ultrasound—A Systematic Review of Randomized Controlled Trials and Meta-Analysis

Healthcare ◽  
2021 ◽  
Vol 9 (4) ◽  
pp. 479
Author(s):  
Tatiana Sidiropoulou ◽  
Kalliopi Christodoulaki ◽  
Charalampos Siristatidis
Keyword(s):  
Systematic Review ◽  
Lumbar Spine ◽  
Randomized Controlled Trials ◽  
Success Rate ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Technical Failure ◽  
Obese Patients ◽  
Randomized Controlled ◽  
Meta Analyses

A pre-procedural ultrasound of the lumbar spine is frequently used to facilitate neuraxial procedures. The aim of this review is to examine the evidence sustaining the utilization of pre-procedural neuraxial ultrasound compared to conventional methods. We perform a systematic review of randomized controlled trials with meta-analyses. We search the electronic databases Medline, Cochrane Central, Science Direct and Scopus up to 1 June 2019. We include trials comparing a pre-procedural lumbar spine ultrasound to a non-ultrasound-assisted method. The primary endpoints are technical failure rate, first-attempt success rate, number of needle redirections and procedure time. We retrieve 32 trials (3439 patients) comparing pre-procedural lumbar ultrasounds to palpations for neuraxial procedures in various clinical settings. Pre-procedural ultrasounds decrease the overall risk of technical failure (Risk Ratio (RR) 0.69 (99% CI, 0.43 to 1.10), p = 0.04) but not in obese and difficult spinal patients (RR 0.53, p = 0.06) and increase the first-attempt success rate (RR 1.5 (99% CI, 1.22 to 1.86), p < 0.0001, NNT = 5). In difficult spines and obese patients, the RR is 1.84 (99% CI, 1.44 to 2.3; p < 0.0001, NNT = 3). The number of needle redirections is lower with pre-procedural ultrasounds (SMD = −0.55 (99% CI, −0.81 to −0.29), p < 0.0001), as is the case in difficult spines and obese patients (SMD = −0.85 (99% CI, −1.08 to −0.61), p < 0.0001). No differences are observed in procedural times. Ιn conclusion, a pre-procedural ultrasound provides significant benefit in terms of technical failure, number of needle redirections and first attempt-success rate. Τhe effect of pre-procedural ultrasound scanning of the lumbar spine is more significant in a subgroup analysis of difficult spines and obese patients.

scholarly journals Comparative efficacy and safety of interventions for treating head lice: a protocol for systematic review and network meta-analysis

2021 ◽  
Vol 5 (1) ◽  
pp. e001129
Author(s):  
Bill Stevenson ◽  
Wubshet Tesfaye ◽  
Julia Christenson ◽  
Cynthia Mathew ◽  
Solomon Abrha ◽  
...  
Keyword(s):  
Systematic Review ◽  
Randomised Controlled Trials ◽  
Meta Analysis ◽  
Grey Literature ◽  
Risk Of Bias ◽  
Controlled Trials ◽  
Head Lice ◽  
Efficacy And Safety ◽  
Randomised Controlled ◽  
Meta Analyses

BackgroundHead lice infestation is a major public health problem around the globe. Its treatment is challenging due to product failures resulting from rapidly emerging resistance to existing treatments, incorrect treatment applications and misdiagnosis. Various head lice treatments with different mechanism of action have been developed and explored over the years, with limited report on systematic assessments of their efficacy and safety. This work aims to present a robust evidence summarising the interventions used in head lice.MethodThis is a systematic review and network meta-analysis which will be reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-analyses statement for network meta-analyses. Selected databases, including PubMed, Embase, MEDLINE, Web of Science, CINAHL and Cochrane Central Register of Controlled Trials will be systematically searched for randomised controlled trials exploring head lice treatments. Searches will be limited to trials published in English from database inception till 2021. Grey literature will be identified through Open Grey, AHRQ, Grey Literature Report, Grey Matters, ClinicalTrials.gov, WHO International Clinical Trials Registry and International Standard Randomised Controlled Trials Number registry. Additional studies will be sought from reference lists of included studies. Study screening, selection, data extraction and assessment of methodological quality will be undertaken by two independent reviewers, with disagreements resolved via a third reviewer. The primary outcome measure is the relative risk of cure at 7 and 14 days postinitial treatment. Secondary outcome measures may include adverse drug events, ovicidal activity, treatment compliance and acceptability, and reinfestation. Information from direct and indirect evidence will be used to generate the effect sizes (relative risk) to compare the efficacy and safety of individual head lice treatments against a common comparator (placebo and/or permethrin). Risk of bias assessment will be undertaken by two independent reviewers using the Cochrane Risk of Bias tool and the certainty of evidence assessed using the Grading of Recommendations, Assessment, Development and Evaluations guideline for network meta-analysis. All quantitative analyses will be conducted using STATA V.16.DiscussionThe evidence generated from this systematic review and meta-analysis is intended for use in evidence-driven treatment of head lice infestations and will be instrumental in informing health professionals, public health practitioners and policy-makers.PROSPERO registration numberCRD42017073375.

scholarly journals Almond Consumption and Risk Factors for Cardiovascular Disease: A Systematic Review and Meta-analysis of Randomized Controlled Trials

2019 ◽  
Vol 10 (6) ◽  
pp. 1076-1088 ◽  
Author(s):  
Michelle A Lee-Bravatti ◽  
Jifan Wang ◽  
Esther E Avendano ◽  
Ligaya King ◽  
Elizabeth J Johnson ◽  
...  
Keyword(s):  
Risk Factors ◽  
Systematic Review ◽  
Blood Pressure ◽  
Cardiovascular Disease ◽  
Body Weight ◽  
Randomized Controlled Trials ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Meta Analyses

ABSTRACT Evidence suggests that eating nuts may reduce the risk of cardiovascular disease (CVD). We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) evaluating almond consumption and risk factors for CVD. MEDLINE, Cochrane Central, Commonwealth Agricultural Bureau, and previous systematic reviews were searched from 1990 through June 2017 for RCTs of ≥3 wk duration that evaluated almond compared with no almond consumption in adults who were either healthy or at risk for CVD. The most appropriate stratum was selected with an almond dose closer to 42.5 g, with a control most closely matched for macronutrient composition, energy intake, and similar intervention duration. The outcomes included risk factors for CVD. Random-effects model meta-analyses and subgroup meta-analyses were performed. Fifteen eligible trials analyzed a total of 534 subjects. Almond intervention significantly decreased total cholesterol (summary net change: −10.69 mg/dL; 95% CI: −16.75, −4.63 mg/dL), LDL cholesterol (summary net change: −5.83 mg/dL; 95% CI: −9.91, −1.75 mg/dL); body weight (summary net change: −1.39 kg; 95% CI: −2.49, −0.30 kg), HDL cholesterol (summary net change: −1.26 mg/dL; 95% CI: −2.47, −0.05 mg/dL), and apolipoprotein B (apoB) (summary net change: −6.67 mg/dL; 95% CI: −12.63, −0.72 mg/dL). Triglycerides, systolic blood pressure, apolipoprotein A1, high-sensitivity C-reactive protein, and lipoprotein (a) showed no difference between almond and control in the main and subgroup analyses. Fasting blood glucose, diastolic blood pressure, and body mass index significantly decreased with almond consumption of >42.5 g compared with ≤42.5 g. Almond consumption may reduce the risk of CVD by improving blood lipids and by decreasing body weight and apoB. Substantial heterogeneity in eligible studies regarding almond interventions and dosages precludes firmer conclusions.

scholarly journals TaiChi and Qigong for Depressive Symptoms in Patients with Chronic Heart Failure: A Systematic Review with Meta-Analysis

2021 ◽  
Vol 2021 ◽  
pp. 1-12
Author(s):  
Wei Jiang ◽  
Shaojun Liao ◽  
Xiankun Chen ◽  
Cecilia Stålsby Lundborg ◽  
Gaetano Marrone ◽  
...  
Keyword(s):  
Heart Failure ◽  
Systematic Review ◽  
Depressive Symptoms ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Therapeutic Effects ◽  
Cochrane Central Register ◽  
China National Knowledge Infrastructure ◽  
Beneficial Effects ◽  
Meta Analyses

Background. Depression is a debilitating comorbidity of heart failure (HF) that needs assessment and management. Along with mind-body exercise to deal with HF with depression, the use of TaiChi and/or Qigong practices (TQPs) has increased. Therefore, this systematic review assesses the effects of TQPs on depression among patients with HF. Methods. Randomized controlled trials (RCTs) that examined the effect of TQPs on depression in patients with HF were searched by five databases (PubMed, Cochrane Central Register of Controlled Trials (CENTRAL), EMBASE, CINAHL, and China National Knowledge Infrastructure (CNKI)). With standardized mean difference (SMD) and 95% confidence intervals (95% CI), random-effects meta-analyses of the effect of TQPs on depressive symptoms were performed. Results. Of eight included RCTs, seven (481 patients) provided data for the meta-analysis. The pooling revealed that TQPs contribute to depression remission in HF (SMD −0.66; 95% CI −0.98 to −0.33, P < 0.0001 ; I2 = 64%). Its antidepressive effect was not influenced by intervention duration or exercise setting, but rather by ejection fraction subtype, depressive severity, and depression instruments. The beneficial effects were preserved when the study with the largest effect was removed. Conclusion. This study suggests that TQPs might be a good strategy for alleviating depressive symptoms in patients with HF. And rigorous-design RCTs, which focus on the identified research gaps, are needed to further establish the therapeutic effects of TQPs for depression in HF.

scholarly journals Mindfulness-based interventions for mental well-being among people with multiple sclerosis: a systematic review and meta-analysis of randomised controlled trials

2019 ◽  
Vol 90 (9) ◽  
pp. 1051-1058 ◽  
Author(s):  
Robert Simpson ◽  
Sharon Simpson ◽  
Nitish Ramparsad ◽  
Margaret Lawrence ◽  
Jo Booth ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Systematic Review ◽  
Randomised Controlled Trials ◽  
Meta Analysis ◽  
Treatment Options ◽  
Well Being ◽  
Controlled Trials ◽  
Medical Subject Headings ◽  
Randomised Controlled ◽  
Mental Well Being

ObjectiveImpairment of mental well-being (anxiety, depression, stress) is common among people with multiple sclerosis (PwMS). Treatment options are limited, particularly for anxiety. The aim of this study was to update our previous systematic review (2014) and evaluate via meta-analysis the efficacy of mindfulness-based interventions (MBIs) for improving mental well-being in PwMS.MethodsSystematic searches for eligible randomised controlled trials (RCTs) were carried out in seven major databases (November 2017, July 2018), using medical subject headings and key words. Studies were screened, data extracted, quality appraised and analysed by two independent reviewers, using predefined criteria. Study quality was assessed using the Cochrane Collaboration risk of bias tool. Mental well-being was the primary outcome. Random effects model meta-analysis was performed, with effect size reported as standardised mean difference (SMD).ResultsTwelve RCTs including 744 PwMS were eligible for inclusion in the systematic review, eight had data extractable for meta-analysis; n=635. Ethnicity, socioeconomic status, comorbidity and disability were inconsistently reported. MBIs varied from manualised to tailored versions, lasting 6–9 weeks, delivered individually and via groups, both in person and online. Overall SMD for mental well-being (eight studies) was 0.40 (0.28–0.53), p<0.01, I2=28%; against active comparators only (three studies) SMD was 0.17 (0.01–0.32), p<0.05, I2 =0%. Only three adverse events were reported.ConclusionsMBIs are effective at improving mental well-being in PwMS. More research is needed regarding optimal delivery method, cost-effectiveness and comparative-effectiveness.PROSPERO registration numberCRD42018093171.

Interferon-beta injection in multiple sclerosis patients is related to the induction of headache and flu-like pain symptoms: a systematic review and meta-analysis of randomised controlled trials

2021 ◽  
Vol 19 ◽  
Author(s):  
Leonardo Gomes Pereira ◽  
Gabriela Trevisan ◽  
Patrícia Rodrigues ◽  
Fernanda Tibolla Viero ◽  
Julia Maria Frare ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Systematic Review ◽  
Adverse Effects ◽  
Randomised Controlled Trials ◽  
Meta Analysis ◽  
Controlled Trials ◽  
First Choice ◽  
Pain Symptoms ◽  
Randomised Controlled ◽  
Multiple Sclerosis Patients

: Multiple sclerosis (MS) is a chronic neurodegenerative, inflammatory and autoimmune disease characterised by the demyelination of the central nervous system. One of the main approaches to treating MS is the use of disease-modifying therapies (DMTs). Among the DMTs are interferons (IFNs), which are cytokines responsible for controlling the activity of the immune system, exerting immunomodulatory, antiviral, and antiproliferative activities. IFN-beta (IFN-β) is the first-choice drug used to treat relapsing-remitting MS. However, the administration of IFN-β causes numerous painful adverse effects, resulting in lower adherence to the treatment. Therefore, this study aimed to investigate the headache and flu-like pain symptoms observed after IFNβ injection in MS patients using a systematic review and meta-analysis of randomised controlled trials. The search of research databases identified 2370 articles. Nine articles were included (three involving IFNβ-1b and six involving IFNβ-1a). All studies included in the meta-analysis had a low risk of bias. Headache and flu-like pain symptoms frequency increased in MS patients treated with IFN-β. Thus, the adverse effects of headache and flu-like pain symptoms appear to be linked to IFN-β treatment in MS. The protocol of the study was registered in the Prospective International Registry of Systematic Reviews.

The Effectiveness of Telemedicine Solutions for the Management of Type 2 Diabetes: A Systematic Review, Meta-Analysis, and Meta-Regression

2021 ◽  
pp. 193229682110646
Author(s):  
Stine Hangaard ◽  
Sisse H. Laursen ◽  
Jonas D. Andersen ◽  
Thomas Kronborg ◽  
Peter Vestergaard ◽  
...  
Keyword(s):  
Systematic Review ◽  
Type 2 Diabetes ◽  
Systematic Reviews ◽  
Meta Analysis ◽  
Cochrane Library ◽  
Controlled Trials ◽  
Sufficient Information ◽  
Meta Regression ◽  
Meta Analyses

Background: Previous systematic reviews have aimed to clarify the effect of telemedicine on diabetes. However, such reviews often have a narrow focus, which calls for a more comprehensive systematic review within the field. Hence, the objective of the present systematic review, meta-analysis, and meta-regression is to evaluate the effectiveness of telemedicine solutions versus any comparator without the use of telemedicine on diabetes-related outcomes among adult patients with type 2 diabetes (T2D). Methods: This review was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. We considered telemedicine randomized controlled trials (RCT) including adults (≥18 years) diagnosed with T2D. Change in glycated hemoglobin (HbA1c, %) was the primary outcome. PubMed, EMBASE, and the Cochrane Library Central Register of Controlled Trials (CENTRAL) were searched on October 14, 2020. An overall treatment effect was estimated using a meta-analysis performed on the pool of included studies based on the mean difference (MD). The revised Cochrane risk-of-bias tool was applied and the certainty of evidence was graded using the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) approach. Results: The final sample of papers included a total of 246, of which 168 had sufficient information to calculate the effect of HbA1c%. The results favored telemedicine, with an MD of −0.415% (95% confidence interval [CI] = −0.482% to −0.348%). The heterogeneity was great (I2 = 93.05%). A monitoring component gave rise to the higher effects of telemedicine. Conclusions: In conclusion, telemedicine may serve as a valuable supplement to usual care for patients with T2D. The inclusion of a telemonitoring component seems to increase the effect of telemedicine.

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